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RefiningValue.bsky.social

@refiningvalue.bsky.social
558 followers 124 following 72 posts

Health economist writing about HEOR/market access, drug development, biopharma refiningvalue.substack.com

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RefiningValue.bsky.social @refiningvalue.bsky.social · 08/04/2025
Not too often you see HRQoL data in drug commercials. Via Ari Gnanasakthy youtu.be/VDFF6MCFzKM?...
youtu.be
Attruby Commercial (2025)
YouTube video by Commercial Archivist
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Liz Essley Whyte @lizessleywhyte.bsky.social · 01/04/2025
Former FDA Commissioner:
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RefiningValue.bsky.social @refiningvalue.bsky.social · 26/03/2025
Nice paper outlining how RWE can be applied in IRA evaluation of drugs academic.oup.com/healthaffair...
academic.oup.com
Use of real-world evidence in the Medicare Drug Price Negotiation Program: A checklist for the Centers for Medicare and Medicaid Services and manufacturers
Abstract. Under the Inflation Reduction Act's (IRA's) - Medicare Drug Price Negotiation Program, the Centers for Medicare & Medicaid Services' (CMS's)
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RefiningValue.bsky.social @refiningvalue.bsky.social · 06/03/2025
Glad to see GLP-1s continue to push expanded direct offerings: www.prnewswire.com/news-release...
prnewswire.com
Novo Nordisk introduces NovoCare® Pharmacy, lowering cost of all doses of FDA-approved Wegovy® (semaglutide) to $499 per month and offering easy home delivery for cash-paying patients
NovoCare® Pharmacy provides direct-to-patient, convenient home shipments of all dose strengths of Wegovy® at a reduced cost of $499 per month for cash-paying...
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RefiningValue.bsky.social @refiningvalue.bsky.social · 05/03/2025
Reports and documentation are a low-hanging fruit for biopharma and can help reduce OpEx, especially that which is currently outsourced to vendors. CSRs, other study reports, payer dossiers, briefing book docs etc etc. Big potential for short to medium-term savings
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RefiningValue.bsky.social @refiningvalue.bsky.social · 19/02/2025
Short-termism driven by personal timelines rule the day. Greater purpose be damned. Would a Vagelos or Termeer have done the same? I would think not, and hopefully history judges the two archetypes accordingly.
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Michael Gilman @gilman.bsky.social · 19/02/2025
Was really expecting more of these people.
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Robert Califf @robcaliff.bsky.social · 17/02/2025
I am grieving for the many talented & dedicated FDA employees who have been mistreated & those left to do the work of protecting public health. Also for those who will be harmed by this among patients and the public. Those who are complicit in their silence will be judged harshly by history.
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Luke Timmerman @luketimmerman.bsky.social · 13/02/2025
Defend the NIH. timmermanreport.com/2025/02/defe...
timmermanreport.com
Defend the NIH - TimmermanReport.com
Too many people don’t believe anymore in the American Dream. But if you can’t dream big, you can’t accomplish big things. Today, the National Institutes of Health — biomedical science itself — is unde...
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Derek Lowe @dereklowe.bsky.social · 12/02/2025
Biopharma companies and CEOs are keeping their heads down at their own peril. They should speak up about what’s happening to the NIH and other science agencies before it’s too late. Silence gives consent. And no one should consent to this.
science.org
Stand Up And Be Counted
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RefiningValue.bsky.social @refiningvalue.bsky.social · 12/02/2025
Of course not reflective of many (most?) of us working in the industry. Unfortunately, anything at NIH today that will lead to a new drug is way too long a time horizon for leadership to worry about personally (chances are they'll be long gone by the time it comes to fruition).
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Chris Geidner @chrisgeidner.bsky.social · 11/02/2025
BREAKING: In response to doctors' lawsuit, Judge John Bates, a George W. Bush appointee, orders CDC, NIH, and FDA to put back up websites and datasets cited by the doctors in their lawsuit as having been relied upon and pulled down without notice. storage.courtlistener.com/recap/gov.us...
TOTE ASTRICT COLOR
DOCTORS FOR AMERICA,
Plaintiff,
Civil Action No. 25-322 (JDB)
OFFICE OF PERSONNEL MANAGEMENT et al.,
Defendants.
ORDER
Upon consideration of [6] Plaintiff's motion for a temporary restraining order, [8]
Plaintiff's supplemental declarations, [9] Defendants' opposition, [10] Plaintiff's reply, the
hearing on February 10, 2025, and the entire record herein, and for the reasons stated in the
accompanying Memorandum Opinion, it is hereby ORDERED that
1. Defendants Department of Health and Human Services, Center for Disease Control, and Food
and Drug Administration (hereinafter "defendants") shall, by not later than 11:59 pm on
February 11, 2025, restore to their versions as of January 30, 2025, each webpage and dataset
identified by Plaintiff on pages 6-12 of its Memorandum of Law in Support of the Motion for
a Restraining Order [ECF No. 6-1];
2. Defendants shall, in consultation with Plaintiff, identify any other resources that DF A members
rely on to provide medical care and that defendants removed or substantially modified on or
after January 29, 2025, without adequate notice or reasoned explanation; and defendants shall,
by February 14, 2025, restore those resources to their versions as of January 30, 2025;
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Mark Cuban @mcuban.bsky.social · 09/02/2025
This is the most relevant article to NIH and research cuts I’ve seen. Imagine if this was today , how many people would be saying “Why are we studying Gila Monsters and their impact on diabetes ? That’s wasted money !” globalnews.ca/news/9793403...
globalnews.ca
How a Canadian scientist and a venomous lizard helped pave the way for Ozempic - National | Globalnews.ca
In 1984, Dr. Daniel Drucker, an endocrinologist from the University of Toronto, discovered a hormone that helped pave the way for popular diabetes drugs such as Ozempic.
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RefiningValue.bsky.social @refiningvalue.bsky.social · 07/02/2025
Pharma bet that Trump>Biden may be tested sooner than I thought w the news of FDA cuts. Especially if review timelines / meeting timelines start getting impacted
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RefiningValue.bsky.social @refiningvalue.bsky.social · 27/01/2025
Some interesting parallels re Deepseek: US-based LLMs and the bio explosion in China:US biotech Still feel it'll be net positive for the industries and consumers at large in both cases
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RefiningValue.bsky.social @refiningvalue.bsky.social · 24/01/2025
I shouldn't try to apply logic here and apologies for the rare political post but if NIH is developing all of the drugs then why are we freezing all of the funding again?
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RefiningValue.bsky.social @refiningvalue.bsky.social · 22/01/2025
Excellent piece and nicely balanced on the "China asset farm" issue. While others' concerns on impact to the US bio ecosystem are understandable I think it's also important to consider the macro impact re impact on overall discovery/development economics.
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Derek Lowe @dereklowe.bsky.social · 06/01/2025
Re-upping this reply thread from last night. Drugs don't come from nowhere, folks. And we're not ripping off the NIH, either.
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RefiningValue.bsky.social @refiningvalue.bsky.social · 26/11/2024
Interesting that Leerink now has a team doing independent cost effectiveness analyses. Seems to be taking more of a GCEA approach. An alternative to ICER? www.leerink.com/article/a-cp...
leerink.com
A CPE Exclusive: Cobenfy™ for Adults Living with Schizophrenia | Leerink Partners
Leerink Partners' Articles – sharing our deep expertise and experience in Healthcare to help fuel our customers' next breakthrough innovation.
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RefiningValue.bsky.social @refiningvalue.bsky.social · 22/11/2024
He also misunderstands (although not the first time) how drug pricing works. Demand is not perfectly inelastic.
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RefiningValue.bsky.social @refiningvalue.bsky.social · 20/11/2024
Fantastic overview of methods to quantify the various components of the ISPOR value flower in GCEA #HEOR #biosky pmc.ncbi.nlm.nih.gov/articles/PMC...
pmc.ncbi.nlm.nih.gov
Valuing the Societal Impact of Medicines and Other Health Technologies: A User Guide to Current Best Practices
This study argues that value assessment conducted from a societal perspective should rely on the Generalized Cost-Effectiveness Analysis (GCEA) framework proposed herein. Recently developed value asse...
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RefiningValue.bsky.social @refiningvalue.bsky.social · 19/11/2024
Did not realize this. Alex Azar-Pence connection too potentially with Lilly HQ in Indianapolis
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RefiningValue.bsky.social @refiningvalue.bsky.social · 19/11/2024
Nice to see more focus on the "lost" voice in the US access landscape. Arguably the most powerful group that is the least called on. Suspect $LLY $NVO can do it because of the cash boon but if successful perhaps we see more of it more broadly down the road
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Pearl Freier @pearlf.bsky.social · 18/11/2024
I'm re-upping this drug development "starter pack" of some Bluesky accounts organized by Greg Medlock—senior director of R&D at Cambridge, MA-based biotech Vedanta Biosciences. See below: #biosky
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RefiningValue.bsky.social @refiningvalue.bsky.social · 18/11/2024
Nice to start seeing some #HEOR posts around here especially as #ISPOREurope kicks off
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RefiningValue.bsky.social @refiningvalue.bsky.social · 17/11/2024
I wonder what GLP-1 patient vote breakdown was the election. “They’re counting on selling it to Americans because we’re so stupid and so addicted to drugs” -RFK on Ozempic www.cnn.com/2024/11/17/h...
cnn.com
Doctors say RFK Jr.’s anti-Ozempic stance perpetuates stigma and misrepresents evidence | CNN
Robert F. Kennedy Jr. has pledged to tackle high rates of chronic diseases such as diabetes and obesity as President-elect Donald Trump’s pick to lead the US Department of Health and Human Services. T...
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Bijan Salehizadeh @bijans.bsky.social · 16/11/2024
Miss Tweetdeck? Try Deck.Blue - thar's the website to access it
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RefiningValue.bsky.social @refiningvalue.bsky.social · 16/11/2024
One thing pharma understands very well as evidenced by the distinct functions of clinical science, TA clinical, stats. Another area where FDA deserves credit via its role in ensuring adequate trial design/ analysis plans at least when it comes to making approval decisions
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RefiningValue.bsky.social @refiningvalue.bsky.social · 15/11/2024
Probably giving too much credit re strategy here, but it's possible Trump knows RFK won't get confirmed. Gives him an "out" on all the pharma and ACA stuff.
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Darren Dahly @statsepi.bsky.social · 15/11/2024
A perhaps overlooked cost of poorly designed clinical trials: Current trial participation is typically an exclusion criteria for enrollment onto other, perhaps better, clinical trials.
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RefiningValue.bsky.social @refiningvalue.bsky.social · 14/11/2024
RFK to be nominated for HHS
media.tenor.com
a man wearing a hat and a red shirt says they are who we thought they were !
ALT: a man wearing a hat and a red shirt says they are who we thought they were !
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RefiningValue.bsky.social @refiningvalue.bsky.social · 14/11/2024
Merck going to China for PD1xVEGF is interesting but not surprising. Another in the ongoing wave as the science has caught up with much better economics vs the US.
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RefiningValue.bsky.social @refiningvalue.bsky.social · 13/11/2024
Nina Kjellson, Canaan Partners talking about how IRA has shifted big pharma view and pushed initial indication revenue expectation higher given IRA, making it harder to take the more traditional approach of starting in smaller maybe quicker indications and then expanding. Via Biopharma Dive Live
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RefiningValue.bsky.social @refiningvalue.bsky.social · 31/10/2024
Interesting post by Ronny Gal on ex-US blockbusters. While they certainly exist, how many cos (aside from Novartis apparently) are thinking this way? And margins / FCF certainly lower in these markets. www.linkedin.com/posts/ronny-...
linkedin.com
Ronny Gal on LinkedIn: 𝗖𝗮𝗻 𝗱𝗿𝘂𝗴𝘀 𝗯𝗲 𝗯𝗹𝗼𝗰𝗸𝗯𝘂𝘀𝘁𝗲𝗿𝘀 𝘄𝗶𝘁𝗵𝗼𝘂𝘁… | 28 comments
𝗖𝗮𝗻 𝗱𝗿𝘂𝗴𝘀 𝗯𝗲 𝗯𝗹𝗼𝗰𝗸𝗯𝘂𝘀𝘁𝗲𝗿𝘀 𝘄𝗶𝘁𝗵𝗼𝘂𝘁 𝗿𝗲𝗹𝘆𝗶𝗻𝗴 𝗼𝗻 𝘁𝗵𝗲 𝗨𝗦? Novartis is very much of a global company – multicultural and… | 28 comments on LinkedIn
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David Shaywitz @dshaywitz.bsky.social · 24/10/2024
Why I believe human causal biology, rigorously applied, combined w good org structure/strong sci leadership/right size, can improve R&D PoS, eg $VRTX, $REGN. Also: emerging tech incl AI can/should/will contribute to next iteration of R&D elevation. In TR: timmermanreport.com/2024/10/yes-... #biosky
timmermanreport.com
Yes We Can: My Response To Skeptical Readers - TimmermanReport.com
Two weeks ago, I wrote about how difficult it is for R&D leaders to “pick winners,” despite the enormous incentives to do so.  I explained how we tend to underestimate the role of chance, and overesti...
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RefiningValue.bsky.social @refiningvalue.bsky.social · 25/10/2024
Well balanced piece on an issue that is still too black and white in commentary. One impact I think we'll see more of is same-class follow-on small molecules for future / earlier settings in oncology. Use the lead asset as part of POC to justify starting pivotal for follow on in earlier settings.
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RefiningValue.bsky.social @refiningvalue.bsky.social · 24/10/2024
Glad to see some nice #biosky discussions lately. Place seems to be picking up and maybe even starting to feel like the good days of the other place
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RefiningValue.bsky.social @refiningvalue.bsky.social · 10/10/2024
I do wonder how much this has to do with where big pharmas sit in major investors' portfolios - ie more stable, cash-generating side v growth portfolio. Would drug dev be better off if companies viewed more as growth vehicles a la Silicon Valley? Then again small bios fill that space in biopharma
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RefiningValue.bsky.social @refiningvalue.bsky.social · 10/10/2024
Some insights and advice from consultants who participated in first round of IRA negotiations. Some nice actionable tidbits including potential role of comparative evidence and RWE in populations of interest : pink.citeline.com/PS155353/Per...
pink.citeline.com
Perspectives From The Front Lines: Navigating The First Round Of Medicare Price Negotiation
<p>Policy experts and consultants recount their experiences shepherding manufacturers through the first round of Medicare price negotiations during a recent webinar.</p>
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RefiningValue.bsky.social @refiningvalue.bsky.social · 09/10/2024
No surprise CBO does not expect GLP-1s to be cost-saving because it is highly unlikely; but important to remember this isn't an est of value, just a financial analysis which is CBO's job. Value includes improvement and extension of people's lives. www.cbo.gov/publication/...
cbo.gov
How Would Authorizing Medicare to Cover Anti-Obesity Medications Affect the Federal Budget?
NotesNotes Unless this report indicates otherwise, all years referred to are federal fiscal years, which run from October 1 to September 30 and are designated by the calendar year in which they end. E...
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RefiningValue.bsky.social @refiningvalue.bsky.social · 30/09/2024
Commercialization risk is very real and often underdiscussed outside investment circles imo including in general pharma pricing/value discussions #biosky
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RefiningValue.bsky.social @refiningvalue.bsky.social · 30/09/2024
Evolving models for innovative drugs; on direct-to-consumer offerings by pharma #biosky open.substack.com/pub/refining...
open.substack.com
Evolving models for innovative drugs
On direct-to-consumer offerings from pharma
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RefiningValue.bsky.social @refiningvalue.bsky.social · 19/09/2024
Amazing patient perspective from John Carroll of Endpoints. Plenty of gaps remain in incentivizing development in high unmet need diseases endpts.com/after-i-was-...
endpts.com
You bet your life: After I was diagnosed with a rare cancer, I discovered how a small band of physician-scientists triggered a revolution
It all started to look seriously bad when my legs began to swell up, which I initially — stupidly — shrugged off. By the time it became apparent that my kidneys had stopped working, I grabbed an Uber ...
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RefiningValue.bsky.social @refiningvalue.bsky.social · 31/08/2024
Watching this I think Matt Gline would make a great elevator speech on "why doesn't pharma spend more on R&D / spend so much on marketing etc etc". Hope he gets more involved in the policy discussion side of things www.biotechtv.com/post/roivant...
biotechtv.com
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Reposted by RefiningValue.bsky.social
Darren Dahly @statsepi.bsky.social · 26/03/2024
ICYMI: Reference Collection to push back against “Common Statistical Myths (cc @f2harrell.bsky.social) discourse.datamethods.org/t/reference-...
discourse.datamethods.org
Reference Collection to push back against
Note: This topic is a wiki, meaning that this main body of the topic can be edited by others. Use the Reply button only to post questions or comments about material contained in the body, or to sugge...
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RefiningValue.bsky.social @refiningvalue.bsky.social · 25/03/2024
Not sure I agree with this take. Who will forego the top/bottomline potential even if short-lived? Incentives would heavily prefer it over not and if anything these cases suggest maybe run up is smaller next time but more sustained (if market learns from the exp).
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RefiningValue.bsky.social @refiningvalue.bsky.social · 07/03/2024
Sanofi's gap between avg US list and net prices was 19+ percentage points in 2023 - largest since before 2016. Also largest gap ever for insulins? #grosstonetbubble
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RefiningValue.bsky.social @refiningvalue.bsky.social · 13/02/2024
Finally watched Breakthrough, the documentary about Jim Allison and the birth of IO. Highly recommend.
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RefiningValue.bsky.social @refiningvalue.bsky.social · 08/02/2024
Recent HTA transparency rules could add to the PR crisis for the industry re difference in US v ex-US prices (likelihood of back-calculation/estimation of post-discount price higher, while post rebate price still relatively opaque in US)
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